Kornimate/medical-research-clean huggingface dataset:
investigation of conservative treatment on adolescent idiopathic scoliosis patients.

Conditions: Adolescent Idiopathic Scoliosis

Summary: aim: it was aimed to investigate the effectiveness of three-dimensional scoliosis exercises and balance-coordination exercises in patients with adolescent idiopathic scoliosis.

method: thirty patients who were diagnosed with adolescent idiopathic scoliosis were randomly divided into three groups. the first group was treated with 3-dimensional scoliosis exercise program according to schroth method, second group was treated with schroth exercises and balance-coordination exercises in addition to brace. exercises were performed for a total of 6 weeks (18 sessions). the third group was treated only with brace and the control group consisted of healthy individuals. patients were assessed for their curve angle (cobb method), rotation angle (scoliometer), spinal flexibility (anterior and lateral bending tests), quality of life (scoliosis research society-22), cosmetic effects (walter reed visual rating scale), balance parameters (balance master system neurocom international inc. clackamas, or, usa ver 8.1), vertical perception (subjective vertical detection test) and brain responses (electroencephalography) were assessed before and after treatment. spss 20.0 statistical program was used for data analysis of the study.

Eligibility criteria:
inclusion criteria: * being diagnosed with adolescent idiopathic scoliosis between the ages of 10-16 and being deemed appropriate for brace use, * cobb angle between 20º -50º, * to be able to continue the program to be applied, * not having a chronic disease that requires the use of any neurological or psychiatric medication, hearing test results are within normal values, * parents allow the child to participate in the study exclusion criteria: * the patient has any contraindications to exercise, * previous spine surgery, * having a curvature of thoracic apex 6 or more, * having any mental problems, * scoliosis is not idiopathic but has occurred for different reasons (neurological, congenital, etc.), * presence of neurological, psychiatric, muscular, rheumatic or orthopedic diseases.
teneligliptin-glimepiride ddi study

Conditions: Diabetes Mellitus

Summary: an open label, one sequence study to investigate the pharmacokinetic drug interaction between teneligliptin and glimepiride in healthy male subjects


Eligibility criteria:
inclusion criteria: 1. healthy male adult aged 20 to 45 years 2. body weight ≥ 50kg, and bmi between 18 and 29 kg/m2 at screening 3. subject who agrees to use a medically acceptable double-barrier method of contraception and not to donate sperms from the first dose until 2 months after the last dose. 4. subject who was given, and fully understood, the information about the study, and has provided voluntary written informed consent to participate in the study and agreed to comply with the study requirements. exclusion criteria:
real-world study comparing the adherence and effectiveness of linagliptin vs. acarbose

Conditions: Diabetes Mellitus, Type 2

Summary: non-interventional cohort study based on newly collected data under routine medical practice of a total of 500 diabetes mellitus, type 2 patients


Eligibility criteria:
inclusion criteria: * patient should fully know and understand the content of consent form, and the patient is willing and able to sign an informed consent form * chinese outpatients with confirmed t2dm * patients of ≥ 18, \< 80 years old * patients currently use metformin monotherapy ≥ 1500 mg/day or maximum tolerable dose and whose glucose levels are not adequately controlled * hba1c ≥ 7% and \< 12% * new user\* linagliptin or acarbose as combination therapy with metformin ≥ 1500 mg/day or maximum tolerable dose \*new user defined as a t2dm patient initiating linagliptin or acarbose as an add-on therapy. these are patients who are on metformin and whose glucose levels are not adequately controlled. exclusion criteria: * type 2 diabetes mellitus patients who previously used any dpp-4 inhibitor/ glp-1 receptor agonist at index date or any agi at index date, are not eligible to participate. also excluded are patients who currently using any glucose-lowering agent as monotherapy other than metformin. * patients with clinically significant acute major organ or systemic disease or other condition judged by the investigator that would create difficulty for the 24-week follow-up. * patients who participated in a clinical trial within 2 months prior to study enrolment date. * patients diagnosed with type 1 diabetes mellitus, secondary diabetes or gestational diabetes. * current treatment with systemic steroids at time of informed consent or within 6 weeks prior to informed consent. * patients with known significant gi disease as judged by the study physician.
geco: implementation and effectiveness of copd case-finding in low and middle income countries

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this study will test how well short questionnaires, with and without a simple breathing test called 'peak flow', can identify people with copd compared to the gold-standard diagnostic test called spirometry. we will test this in 10,500 people from three low- and middle-income countries, namely nepal, peru and uganda. we will also examine the feasibility of implementing our case-finding intervention at scale.

the investigators will determine whether case-finding for copd can be facilitated using 5-item questionnaires with and without a measurement of peak-flow. the investigators hypothesise that 5-item questionnaires will be a valid case-finding tool for copd in lmic and will be acceptable and feasible for use in these settings. 1. clinical aim: determine the diagnostic accuracy of the case-finding questionnaires with and without pef. 2. implementation aim: assess the appropriateness, acceptability and feasibility of using questionnaires and pef to identify copd cases from the perspective of local community members, community health workers, local health centre physicians and ministries of health. the design of the intervention will be informed by formative work prior to commencement of the main study. study fieldworkers will enroll and screen a randomly-selected age- and sex-stratified population sample of adults aged ≥40 years; a total of 10,500 between the following three countries in the catchment areas of existing community census areas in bhaktapur (nepal), lima (peru), and nakaseke (uganda). the investigators will report the sensitivity, specificity and positive predictive value of the case-finding questionnaire, with and without pef, in relation to a gold standard copd diagnosis made at spirometry (post-bronchodilator fev1/vc ratio \<lln, with a history of significant respiratory exposure to tobacco smoke or biomass). the investigators will construct roc curves to visualise trade-offs in sensitivity and specificity across a range of questionnaire cut off values. the investigators will also examine the feasibility of implementing a 5 item questionnaire +/- pef intervention at scale.

Eligibility criteria:
inclusion criteria: * male or female participants aged ≥40 years * full-time resident in the area (living in area \> 6 months) * able to perform adequate quality spirometry * capable of providing informed consent exclusion criteria: * pregnancy (self-reported) * currently has active pulmonary tb or is taking medications for pulmonary tb

Keywords: copd spirometry copd diagnosis pef case finding lmic
an observational study of patients with chronic liver disease

Conditions: Chronic Liver Disease; Cirrhosis

Summary: target-liver disease (target-ld) is an observational research study to conduct a comprehensive review of outcomes for patients with chronic liver disease (cld).


Eligibility criteria:
inclusion criteria: disease cohort •adult\* patients at the time of enrollment with a diagnosis of cld/cirrhosis by icd-10 code in the ehr interface engaged cohort * adult\* patients diagnosed and managed for cld/cirrhosis invited to participate * ability to provide written informed consent exclusion criteria: disease cohort * death * manual removal (sponsor or site request) * no ehr interface encounter \> 3 years. engaged cohort * patient expressed desire to withdraw consent to complete pros * failure to complete pros within 24 weeks of initial invitation * greater than 24 months lapse of survey completion after baseline surveys completed * additionally, the criteria detailed for disease cohort apply to the engaged cohort.
pressure ulcer formation prevention in paraplegics using computer and sensory substitution via the tongue.

Conditions: PARAPLEGIA

Summary: will the use of sensory substitution by lingual electric stimulation improve in a suitable way, for paraplegic subject, the spatial distribution of pressure applied at the seat/skin interface in order to prevent the formation of pressure ulcer? we will try to demonstrate that paraplegic subject move in an appropriate matter, in term of pressure, after a movement way advised by periodical electric stimuli on the tongue.

the objective of this study will be, to validate or not, the possibility to inform, in a suitable way, paraplegic subject by a lingual electric stimulation. two a and b study groups of paraplegic subjects will be built-up in a randomized way. under standardized conditions, the a study group subject will modify his usual behavior by using the cosmetically acceptable interface to get back information for moving his chest in a suitable way in order to correct identified maxima of pressure at the seat/skin interface. under the same conditions but without the developed device, the b study group subject will have an usual behavior. the analysis of the different behavior in these two groups will enable to evaluate, in an objective way, the potential interest of this new medical device for the prevention of pressure ulcer.

Eligibility criteria:
inclusion criteria: * patient affiliated to social security or similarly regime * paraplegic medullary patient * more or equal than 18 years old. exclusion criteria: patients will be excluded if at least one of the following criteria is present : * pregnancy and feeding women * persons without liberty by administrative or judiciary decision * persons hospitalized without consent * persons concerned by a justice protection action * dependant major person * palatine prosthesis intolerance * buttock pressure ulcer evolution * acute pathology (particularly mouth level) * nickel allergy * impossibility to use the medical device, to understand or realize the protocol due to cognitive pathologies. * patient with dental troubles incompatible with the realisation or utilisation of orthodontic prothesis. * no tactile feeling with tongue, * impossibility to set up the orthodontic prothesis due to superior limb deterioration

Keywords: pressure ulcer lingual electric stimulation paraplegic patient pressure ulcer/prevention & control
evaluation of lactest for the diagnosis of hypolactasia in adults and elderly patients presenting with clinical symptoms of lactose intolerance

Conditions: Lactose Intolerance

Summary: the purpose of this study is to evaluate both the impact of lactest on diagnostic thinking and on patient management, and its reproducibility (test-retest), for the diagnosis of hypolactasia in adults and elderly patients presenting with clinical symptoms of lactose intolerance.


Eligibility criteria:
inclusion criteria: 1. adults of either sex, between 18 and 70 years old. 2. capacity for understanding and giving the informed consent to participate in this study. 3. patients with clinical suggestive of lactose intolerance, primary or secondary, who have not been diagnosed and that fulfil the requirements allowed by the gaxilose summary of product characteristics (smpc). exclusion criteria: 1. pregnant women or breast-feeding women. 2. unable or reticent to give the informed consent or to comply with the study requirements. 3. patients with glomerular filtration rate (gfr) less than 90 ml/min/1.73m2. 4. portal hypertension: ascites, cirrhosis. 5. medical records of total gastrectomy and/or vagotomy. 6. patients diagnosed with myxedema. 7. patients with diabetes mellitus. 8. patients who are participating or have participated in any clinical trial within the 3 months previous to their inclusion in the study. 9. patients who are drug abuse consumers. 10. patients under treatment with antibiotics, sulphamides and antiparasitics, who cannot suspend the treatments 7 days prior to the performance of the hydrogen breath test. 11. patients with any recognized and already existing disorder that might interfere with the any of the lactose intolerance diagnosis tests. 12. patients who have taken aspirin of indomethacin in the 48h preceding the performance of the gaxilose test.
investigator initiated clinical study to explore the efficacy and safety of human placenta hydrolysate in the chronic fatigue patients

Conditions: Chronic Fatigue Syndrome; Idiopathic Chronic Fatigue

Summary: gcjbp laennec injection contains a variety of cytokines derived from human placenta, amino acids, peptides, nucleobases, and carbohydrates. this product is approved for improving liver function. also, it has been prescribed for lots of diseases such as menopausal disorders, atopic dermatitis, skin cares as well as fatigue for long time. although its action mechanism and clinical effectiveness are not still clear, there are reports which say a strong probability of its clinical effectiveness in the chronic fatigue patients. this study aims to investigate the safety and efficacy of gcjbp laennec inj. (human placenta hydrolysate) in the chronic fatigue patients through a randomized controlled tial.


Eligibility criteria:
inclusion criteria: * patient diagnosed with chronic fatigue syndrome or idiopathic chronic fatigue * given written informed consent * male or female aged between 20 and 65 * patient who can read and answer to written questionnaires * patient who agrees to visit clinic for study drug injection 3 times per a week for 6 weeks exclusion criteria: * patient who has been administrated with any other investigational product for 28 days prior to screening visit * patient who is pregnant or childbearing potential female patient who does not consent for contraception during the study * patient who has a hypersensitivity provoked by study drug or others drived from animals * patient who has been received with any human placenta product for 6 months before study participation * abnormal liver function * abnormal renal function * back depression inventory (bdi) ii is more than 29 * underlying disease/conditions, in the investigator's judgment, which will be unable to participate in the study

Keywords: chronic fatigue cfs icf human placenta
tolerability of cannabis in patients receiving concurrent chemoradiation for glioblastoma

Conditions: Glioblastoma

Summary: the goal of this single arm phase i feasibility study is to investigate the tolerability of cannabis with concurrent chemoradiation in the treatment of glioblastoma multiforme (gbm). a strain of cannabis provided by the national institute of drug abuse (nida) that has a high concentration of cannabidiol (cbd) and a low concentration of thc (relative to average street cannabis) will be tested in order to maximize clinical efficacy while minimizing intoxicating side effects in this medically-ill population.

the purpose of this study is to determine the feasibility and the effects of cannabis with high concentrations of cbd in patients receiving chemoradiation for gbm. this is not a therapeutic study for the treatment of glioblastoma. patients will first complete a cannabis sampling session to assess for initial marijuana tolerability. proceeding this, patients will complete 3-5 outpatient smoking sessions per week over a 6 week period. during each session, patients will be given 90 minutes to smoke 0.5 to 2 cannabis cigarettes. outcome measures will include measures of pain, mood, nausea, quality of life, and the both the potentially positive and negative subjective effects of cannabis. food intake, opioid use, and compliance to cannabis treatment will be investigated. it is hypothesized that concurrent use of cannabis with chemoradiation in the treatment of patients with gbm will be feasible, well tolerated and may decrease radiation-induced toxicities.

Eligibility criteria:
inclusion criteria: * diagnosis of glioblastoma requiring standard care chemoradiation of concurrent temozolomide and 60 gy of radiation given over 30 treatments * age 21-70 * able to give informed consent, and comply with study procedures exclusion criteria: * meet dsm-v criteria for current major psychiatric illness, such as bipolar disorder, major depression, active suicidal intent, or psychosis that could be exacerbated by the administration of cannabis * meet dsm-v criteria for major neurological disorder, such as mild cognitive impairment or neurodegenerative disorders (such as movement disorders, dementia), that could be exacerbated by the administration of cannabis. * women who are not practicing an effective form of birth control (condoms, diaphragm, birth control pill, iud) or currently pregnant. * current (weekly) use of cannabis. * patients on supplemental oxygen or history of chronic obstructive pulmonary disease (copd). * cardiovascular disease * compromised immunity * patients with a history of substance use disorder other than nicotine, such an opiate use disorder.

Keywords: gbm who grade iv
fugal infection in covid-19 patients

Conditions: Covid19

Summary: screening early detection of invasive fungal sinusitis in covid-19 positive patients

severe acute respiratory syndrome coronavirus-2 (sars-cov-2); the causative organism of coronavirus disease 2019 (covid-19); infects primarily the lungs leading to more than 100 million covid-19 cases around the world, resulting in almost three million deaths. covid-19 spectrum of symptoms expanded from upper respiratory tract infection to extensive viral pneumonia and respiratory failure. covid-19 patients are highly susceptible to superimposed secondary infection especially fungal infections. acute invasive fungal sinusitis (aifs) is one of the most aggressive forms of sinusitis that is commonly present in immunocompromised patients and frequently leads to significant mortality and morbidity. mucormycosis a life threatening aifs characterized by hyphal invasion and massive destruction of maxillofacial structures. histological characters include mycotic infiltration of vessels with propensity to tissue infarction. in addition to other fungi such as acinetobacter, klebsiella, enterobacter, aspergillus and candida that frequently lead to secondary fungal infection in covid-19 patients. the co-existence of covid-19 and aifs is due to immune dysregulation in covid-19 patients as both cd4+ and cd8+ t lymphocytes are suppressed thus impair patients' innate immunity. in addition to the extensive use of steroids, broad spectrum antibiotics and monoclonal antibodies may contribute in fungal infection. covid-19 patients with pre-existing conditions such as untreated hiv, organ transplantation, un controlled diabetes and malignancies are more susceptible to aifs on the contrary covid-19 patients with underlying chronic disease such as hypertension, chronic kidney and chronic heart disease usually are not associated with more risk of aifs. taking in consideration raised incidence of morbidity and mortality associated with aifs and on the other hand limited studies available especially in middle east region raised the importance of studying the incidence and the behaviour of aifs in covid-19 patients. this study aims to to assess the occurrence of aifs superinfections in patients with covid-19.

Eligibility criteria:
inclusion criteria: * patients who were diagnosed with invasive fungal sinusitis, and are survivors of covid19 infection, all cases diagnosed on the basis of the interim guidance of the world health organization (who) for diagnosis of sars-cov-2. exclusion criteria: * - patients who received antifungal therapy within three days prior to sample collection. * patients refused to participate in the study.

Keywords: covid-19, invasive fungal infection
the use of maternal serum unconjugated estriol for monitoring the prevention of neonatal respiratory distress syndrome

Conditions: Neonatal Respiratory Distress Syndrome

Summary: the objective of this project is to evaluate clinical significance of measuring maternal blood estriol levels, after the administration of antenatal corticosteroids to enhance lung maturity. the investigators will test for associations of the change in maternal estriol with the development of respiratory distress syndrome. the investigators are also interested in determining whether salivary estriol is a valid surrogate to estriol blood assays. in addition the investigators will correlate these changes to pharmacokinetic (pk), pharmacodynamics (pd), and pharmacogenetic measures of betamethasone administration and fetal respiratory outcome

we will obtain serum and saliva for estriol measurement before or within 2 hours of antenatal corticosteroid administration and about 24 hours after each dose is given. women who consent to an optional pk portion of the study will have plasma samples obtained pre-dose and then on a schedule of approximately 0.5-2, 4-8, 10-15, 22-24 hours after the first dose and then 6-8, 24, and 48 hours after the 2nd dose. one sample will be collected in each of these times. a sample of whole blood will be obtained for dna isolation. at the time of delivery, umbilical cord blood will be collected before being discarded for dna and plasma. if we are unable to obtain umbilical cord blood, a buccal swab will be collected from the baby for dna extraction.

Eligibility criteria:
inclusion criteria: * gestational age between 23-34 weeks with a diagnosis of threatened preterm labor or preterm premature rupture of membranes, or other diagnosis with a high likelihood of preterm delivery where the provider is recommending administering antenatal corticosteroids * singleton gestation * live fetus at the time of enrollment * being administered antenatal corticosteroids to enhance lung maturity * ability to provide written informed consent to participate in the study exclusion criteria: * • maternal age \<18 years old * major congenital anomalies * multiple gestations
medical safety follow-up study for patients who received more than 28 days of total exposure to bgg492

Conditions: Adrenocortical Adenoma; Endometrial Stromal Sarcomas

Summary: to provide medical follow-up to patients exposed to bgg492 for more than 28 days in study cbgg492a2207 (nct 01147003) and/or cbgg492a2212 (nct 01338805).

the purpose of the study was to provide medical follow-up to patients exposed to bgg492 for more than 28 days in study cbgg492a2207 (nct 01147003) and/or cbgg492a2212 (nct 01338805). data from study cbgg492a2216 was used to support the clinical safety assessment of bgg492 regarding the observance of uterine endometrial stromal tumors and adrenal cortical adenomas at least one year after the completion of bgg492 treatment.

Eligibility criteria:
inclusion criteria: 1. written informed consent had to be obtained before any assessment was performed; 2. patients had to be cooperative, willing to participate in the study assessments, and be able to report aes (adverse events) themselves or have a caregiver who can record and report the events; 3. total exposure to bgg492 treatment in study bgg492a2207 and/or bgg492a2212 had to have been greater than 28 days 4. at least 1 year had to have elapsed since the patient received his or her last dose of bgg492. exclusion criteria: - there were no exclusion criteria for this study. all patients meeting the inclusion criteria were eligible to participate in the follow-up safety assessments

Keywords: adrenocortical adenoma, endometrial stromal sarcomas bgg492